[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54898-54899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30DAY-01-00]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-7090. Send written 
comments to CDC, Desk Officer; Human Resources and Housing Branch, New 
Executive Office Building, Room 10235; Washington, DC 20503. Written 
comments should be received within 30 days of this notice.

[[Page 54899]]

Proposed Project

    1. Evaluation of the Effectiveness of Targeted Lookback for 
Identifying Transfusion Recipients Who Receive Blood That May Have 
Contained Hepatitis C Virus--NEW--National Center for Infectious 
Disease (NCID)--The Food and Drug Administration (FDA) has recently 
issued guidelines for notification of persons who received blood or 
blood components from donors who subsequently tested positive for 
antibody to hepatitis C virus (anti-HCV) using a licensed multiantigen 
assay. 1 Blood collection establishments will identify 
potentially HCV-contaminated blood products and inform transfusion 
services of these units. The transfusion services will then attempt to 
notify the recipients of these products and encourage these recipients 
to be tested for HCV infection. CDC, in collaboration with the Agency 
for Health Care Policy and Research (AHCPR) and the FDA, has been 
charged with the responsibility of evaluating this nationwide 
notification process. The objective of this study is to evaluate the 
effectiveness of the targeted lookback for identifying persons infected 
with HCV, obtaining appropriate medical follow-up, and promoting 
healthy lifestyles and behaviors. The evaluation has three specific 
aims:
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    \1\  Food and Drug Administration. Guidance For Industry. 
Current Good Manufacturing Practice for Blood and Blood Components: 
(1) Quarantine and Disposition of Units from Prior Collections from 
Donors with Repeatedly Reactive Screening Tests for Antibody to 
Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the 
Notification of Consignees and Blood Recipients of Donor Test 
Results for Anti-HCV. Rockville, MD: Center for Biologics Evaluation 
and Research, FDA; September 1998.
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    1. Determine the effectiveness of targeted lookback for identifying 
prior transfusion recipients with HCV infection, including the 
proportion of recipients identified who are ultimately tested, the 
proportion of those tested who are HCV positive, the reasons persons do 
not receive notification, and the reasons persons do not avail 
themselves of testing.
    2. Determine the effectiveness of targeted lookback for encouraging 
and obtaining appropriate medical follow-up and promoting healthy 
lifestyles and behaviors among persons found positive for HCV 
infection, including proportion of HCV-positive persons who seek 
medical evaluation and outcome of that evaluation (severity of liver 
disease, anti-viral therapy, quality of counseling), and reactions/
impact of notification on HCV-negative persons.
    3. Determine the cost-effectiveness of targeted lookback, including 
resources (cost, personnel, etc.) utilized by blood collection groups 
and transfusion services for implementation and costs of medical 
evaluation and management.
    The evaluation will comprise the following components:
    1. A nationwide survey of blood collection establishments.
    2. A nationwide survey of transfusion services.
    3. A follow-up study of transfusion recipients presumed to have 
been notified of their potential HCV exposure. This detailed study will 
involve contacting and interviewing transfusion recipients from a 
sample of transfusion services in defined geographic areas.
    4. A follow-up study of notified transfusion recipients who obtain 
HCV testing offered by blood collection centers.
    The total annual burden hours are 12,040.

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                                                                                     Number of     Avg. burden/
                           Respondents                               Number of      responses/     response  (in
                                                                    respondents     respondents       hours)
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Blood collection establishments.................................             140               1               5
Transfusion services............................................           5,000               1               5
Transfusion recipients (first telephone contact)................           5,000               1             0.2
Transfusion recipients (second telephone contact)...............           2,000               1             0.5
Transfusion recipients (follow-up interview and study)..........             200               3             0.5
Transfusion recipients (first interview of recipients tested at              500               1             0.2
 ARC/ABC).......................................................
Transfusion recipients (follow-up interview and study of                     100               3             0.5
 recipients tested at ARC/ABC)..................................
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    Dated: October 4, 1999.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 99-26272 Filed 10-7-99; 8:45 am]
BILLING CODE 4163-18-P